- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07919574
Effectiveness of Kinesio Taping as an Adjunct to Conservative Treatment in Women With Lipedema
Effectiveness of Kinesio Taping as an Adjunct to Conservative Treatment in Women With Stage II Lipedema: A Prospective, Randomized Controlled Trial
This prospective, randomized controlled trial aims to evaluate the effectiveness of kinesio taping as an adjunct to standard conservative treatment in women with stage II lower-extremity lipedema.
A total of 30 women will be randomly assigned to two groups: a control group receiving standard conservative treatment and an intervention group receiving kinesio taping in addition to standard conservative treatment. Both groups will receive patient education, physical activity recommendations, and a standardized home exercise program. The intervention group will additionally receive bilateral lower-extremity kinesio taping twice weekly for six weeks.
Participants will be assessed at baseline, week 6 (end of treatment), and week 10 (four-week follow-up). The primary outcome will be the change in pain intensity measured using the Visual Analog Scale (VAS) at week 6. Secondary outcomes will include lower-extremity functional status (LEFS), quality of life (EQ-5D-3L), walking performance (4-meter walk test), lower-extremity circumference measurements, and pressure pain threshold assessed using an algometer.
The study aims to determine whether adding kinesio taping to standard conservative treatment provides additional clinical benefits in women with lipedema.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hatice Zehra FERHATLAR
- Phone Number: 05367387869
- Email: haticezehraferhatlar@gmail.com
Study Locations
-
-
Istanbul
-
Küçükçekmece, Istanbul, Turkey (Türkiye), 34307
- Recruiting
- Kanuni Sultan Suleyman Training and Research Hospital
-
Contact:
- Hatice Zehra FERHATLAR, MD
- Phone Number: 05367387869
- Email: haticezehraferhatlar@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
**Inclusion Criteria:**
- Female participants aged 18-65 years.
- Clinical diagnosis of stage II bilateral lower-extremity lipedema.
- Ability to walk independently.
- Ability and willingness to comply with the treatment and assessment schedule throughout the study.
- Provision of written informed consent.
**Exclusion Criteria:**
- Presence of primary or secondary lymphedema or lipolymphedema.
- Pregnancy or breastfeeding.
- Active infection, cellulitis, open wounds, or active dermatological disease in the areas where kinesio taping will be applied.
- Known allergy or hypersensitivity to kinesio tape or its adhesive components.
- Active deep vein thrombosis or thromboembolic disease.
- Severe neurological, rheumatological, or orthopedic disorders that may significantly affect lower-extremity function or walking performance.
- Severe cardiac, renal, or hepatic failure.
- Lipedema-related surgery or liposuction within the previous three months.
- Concurrent participation in another intensive physical therapy or manual lymphatic drainage program that may affect study outcomes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Conservative Treatment + Kinesio Taping
|
Kinesio taping will be applied bilaterally to the lower extremities of participants in the experimental group twice weekly for six weeks, for a total of 12 applications. Kinesio taping will be administered in addition to standard conservative treatment. Standard conservative treatment will consist of patient education regarding lipedema and symptom management, physical activity recommendations, and a standardized lower-extremity home exercise program. This treatment will be provided to participants in both groups during the six-week intervention period. |
|
Active Comparator: Conservative Treatment Alone
|
Standard conservative treatment will consist of patient education regarding lipedema and symptom management, physical activity recommendations, and a standardized lower-extremity home exercise program. This treatment will be provided to participants in both groups during the six-week intervention period. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Pain Intensity Measured by the Visual Analog Scale (VAS)
Time Frame: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Lower Extremity Functional Scale (LEFS) Score
Time Frame: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
|
Change in Health-Related Quality of Life Measured by EQ-5D-3L
Time Frame: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
|
Change in Walking Performance Assessed by the 4-Meter Walk Test
Time Frame: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
|
Change in Lower Extremity Circumference Measurements
Time Frame: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
|
Change in Pressure Pain Threshold (PPT) Measured by Algometry
Time Frame: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Michelini S, Musa F, Vetrano M, Santoboni F, Nusca SM, Latini E, Trischitta D, Michelini S, Iosa M, Vulpiani MC. Defocused and Radial Shock Wave Therapy, Mesotherapy, and Kinesio Taping Effects in Patients with Lipedema: A Pilot Study. Lymphology. 2023;56(1):13-26.
- Rio-Gonzalez A, Delgado-Perez E, Garcia-Garcia E, Gonzalez-Fernandez L, Garcia-Isidoro S, Cerezo-Tellez E. Physiotherapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery-Observational Study. J Clin Med. 2025 Mar 21;14(7):2137. doi: 10.3390/jcm14072137.
- Fetzer A. Specialist approaches to managing lipoedema. Br J Community Nurs. 2016 Apr;Suppl:S30-5. doi: 10.12968/bjcn.2016.21.Sup4.S30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIPE-KT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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